Effect of Mannitol 20% Versus Hypertonic Saline 7.5% in Brain Metabolism and Oxygenation

NCT03573999 | Completed Phase 4

• 1 other identifier: OsmoMetOx
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Usage of osmotic agents is a standard practice in neuroanesthesia since cerebral edema is a very common situation for patients with pathology in the brain. Cerebral edema is defined as the accumulation of fluid in the intracellular or extracellular compartments of the brain. Among other situations that have nothing to do with the brain, a supratentorial pathology such as a tumor, traumatic injury or an aneurysm, will lead to disruption of blood-brain barrier, and energy crisis of the cells that will cause mainly vasogenic and cytotoxic cerebral edema. The most common monitoring method for "measuring" cerebral edema is ICP (intracranial pressure) in which normal values are (with differences in the bibliography) 10-15 mmHg. The osmotic agents used most in neuroanesthesia are mannitol 20% and hypertonic NaCl 7.5% or 3%. Their brain relaxation effectiveness is supposed to be quite the same between the two different agents. Their main difference is that mannitol induces diuresis. Also, electrolyte disorders are another possibility after mannitol infusion. On the other hand, NaCl 7.5% causes vasodilation, does not induce diuresis and hemodynamically, even though it reduces SBP, it raises CO because of its excessive vasodilation. But both reduce cerebral edema due to the change of osmotic pressure in the vessels, that leads to extracting water from brain cells. A supratentorial craniotomy is de facto worsening the oxygenation and metabolism condition of the surgical site, adding to the problem the intracranial pathology causes in the first place. So if oxygen provided is low and the metabolic rate is high, the rate of anaerobic metabolism will raise. Measuring the oxygen in the jugular bulb is the most reliable monitoring method of cerebral oxygenation and metabolism. It becomes evident that optimization of cerebral oxygenation during a craniotomy will possibly affect the outcome of a patient, by improving it. So, if any superiority of one osmotic agent over the other could be demonstrated this will be very helpful in the decision making in routine clinical practice.

Conditions

Brain Edema; Metabolic Disturbance; Electrolyte and Fluid Balance Conditions

Keywords

mannitol; hypertonic saline; brain metabolism; brain oxygenation

Outcome Measures

Primary Outcomes (1)

• Changes of jugular venous oxygen saturation

  Alterations in jugular venous oxygen saturation (%) after intravenous infusion of isosmotic doses of mannitol 20% and hypertonic saline 7.5%

  15 minutes after the end of the infusion of the tested osmotic agent

Secondary Outcomes (4)

• Changes of S-100b protein

  6 hours after the end of the infusion of the tested osmotic agent

• Changes in the cardiac index

  15 minutes after the end of the infusion of the tested osmotic agent

• Brain tension after intravenous infusion of isosmotic doses of mannitol 20% and hypertonic saline 7.5% assessed by Brain relaxation Score and subdural pressure

  2 minutes before dura opening

• Functional outcome of participants

  7 days post surgery

Study Arms (2)

Mannitol 20%

ACTIVE COMPARATOR

Mannitol 20% (4.6ml/kg) will be administered 20 minutes before dura matter opening.

Drug: Mannitol

Hypertonic saline 7.5%

EXPERIMENTAL

Hypertonic saline 7.5% (2ml/kg) will be administered 20 minutes before dura matter opening

Drug: NaCl 7.5%

Interventions

Mannitol DRUG

4.6 ml/kg will be administered before dura opening

Mannitol 20%

NaCl 7.5% DRUG

2 ml/kg will be administered before dura opening

Hypertonic saline 7.5%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 75 years
• ASA Physical status 1 to 3
• Elective or semi-elective supratentorial craniotomy
• Signed informed consent

You may not qualify if:

• Craniotomy for suprasellar pathologies
• Re-craniotomy at the same site
• Perioperative sodium disorders (Na \<130 mEq/L or \>150 mEq/L)
• Administration of intravenous mannitol or hypertonic saline 7.5% 24 hours or less before the surgery
• Preoperative obstructive hydrocephalus
• Congestive heart failure
• Renal failure

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (2)

AHEPA University Hospital

Thessaloniki, 56224, Greece

Location

Georgia Tsaousi

Thessaloniki, 56346, Greece

Location

MeSH Terms

Conditions

Brain Edema

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Georgia Tsaousi

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 29, 2018
• Study Start: June 29, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 20, 2019
• Last Updated: May 7, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)